The non-approvable letter stated that additional information would be required to address remaining questions. BDSI says that it has requested a meeting with the FDA regarding their notification and will use the outcome of this meeting to evaluate the direction it intends to pursue regarding Emezine.
“We are extremely surprised and disappointed by the FDA’s decision in light of the fact that we strictly adhered to the development program that was outlined in our pre-NDA meeting with the FDA in March of 2004,” stated Dr Mark Sirgo, president and CEO of BDSI.
Emezine is an oral transmucosal medication for the treatment of nausea and vomiting. The current alternatives to oral tablets are injections and suppositories. BDSI licenses Emezine on an exclusive basis in the US from UK-based Reckitt Benckiser Healthcare Limited.